Orthoses and support devices are technical aids destined to supplement or correct a deficiency or to compensate for a limitation, or even to increase the physiological performance of a member which has lost its function, has never fully developed, or is affected by a congenital anomaly.
Foot orthoses, for example, are generally used to correct different types of malfunctions, such as high arch or a flat foot. A patient requiring an orthosis typically needs to visit an orthotist at least twice in order to receive his or her orthosis. During the first visit, the orthotist will evaluate the patient and proceed with a print or impression of the foot of the patient. During the process of taking the imprint of the patient's foot, different types of forces need to be applied to the foot in order to understand the correction required, and these forces are very difficult to measure when not impossible. These forces often interfere with the apparatus used to take the prints or impressions of the foot. The corrections required for a numerical imprint are often based on a pre-established computer model which does not take into account the different characteristics of the patient's foot. In addition, modifications or adjustments to be made to the orthotics are usually made using percentages, which makes it difficult to perform the sometimes specific and particular corrections which are required but which are usually not compatible with the pre-established model.
Once a model of the orthosis is numerically obtained, the orthosis is usually manufactured externally in specialized laboratories, or the manufacturing can be done on the orthotist's premises using a specialized machine. Once the orthosis is made, the patient needs to return to the orthotist for at least one more visit so as to try on the orthosis and to determine whether the orthotist needs to further modify or adapt the orthosis to the patient's foot. This modification may be done by sanding or grinding the orthosis until the desired shape is obtained.
U.S. Pat. No. 4,470,782 to ZIMMERMANN describes an apparatus from producing custom orthoses which include a flat substrate pad and an elastic skin to form an expandable interior chamber. Drive pins are put in contact with the arch of a patient in order to maintain the foot in proper alignment for the injection of a moulding material.
The following US patents are also known to the Applicant: U.S. Pat. Nos. 5,275,775; 5,203,793; 5,095,570; 5,042,100; 4,962,762; 4,211,019; 4,128,951; 3,444,586 and 3,121,430.
In light of the preceding, there is a need for a preform which can be used in the making of an orthosis, and which can be manufactured during a single visit to the orthotist. There is also a need for an orthosis which can be easily adjusted and corrected so as to match the specific characteristics of each patient's foot. There is also a need for a process or method for manufacturing such an orthosis, and for an apparatus for manufacturing the orthosis. It would also be desirable if the orthosis could remain inexpensive and easy to manufacture.